Zinnat

Patient Information Leaflet

Caution! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Zinnat (Zinat)
500 mg, film-coated tablets
Cefuroximum
Zinnat and Zinat are trade names of the same medicinal product written in Polish and Bulgarian, respectively.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Zinnat is and what it is used for
2. Important information before taking Zinnat
3. How to take Zinnat
4. Possible side effects
5. How to store Zinnat
6. Contents of the pack and other information

1. What Zinnat is and what it is used for

Zinnat is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Zinnat is used to treat infections of:

• Throat
• Sinuses
• Middle ear
• Lungs or chest
• Urinary tract
• Skin and soft tissues

Zinnat may also be used:

• In the treatment of early-stage Lyme disease (borreliosis – an infection transmitted by ticks).

Your doctor may investigate which type of bacteria has caused your infection and may check during treatment whether the bacteria are sensitive to Zinnat.

2. Important information before using Zinnat

When not to use Zinnat: Page 1 of 6

• if the patient is allergic to cefuroxime axetil, to any of the cephalosporin antibiotics, or to any of the other ingredients of Zinnat (listed in section 6);
• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if the patient has ever developed severe skin rash, peeling of the skin, blisters and (or) mouth ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group;
• If any of the above circumstances apply to the patient, the patient should not take Zinnat without consulting a doctor.

Warnings and precautions
Severe skin adverse reactions have occurred during treatment with cefuroxime, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and
systemic symptoms (DRESS). If any of the symptoms associated with severe skin reactions described in
section 4 are observed, medical advice should be sought immediately.
Before starting treatment with Zinnat, discuss this with your doctor or pharmacist.
Children
Zinnat is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine have not been established in this age group.
During treatment with Zinnat, attention should be paid to the occurrence of such symptoms as
allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhoea (pseudomembranous
colitis). This will reduce the risk of complications.
See “Symptoms to be aware of” in section 4.
Blood tests
Zinnat may affect the results of blood sugar tests and a blood test known as the Coombs test. If the patient is to undergo blood tests, the patient should:

• inform the person taking the blood sample that they are taking Zinnat.

Zinnat with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

• Medicines reducing stomach acid (e.g. antacids used to treat heartburn) may affect the action of Zinnat.
• Probenecid.
• Oral anticoagulants.
• If the patient is taking any of the above (or similar) medicines, they should inform their doctor or pharmacist.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Zinnat may cause dizziness and other adverse effects that may impair the patient's alertness.

• The patient should not drive or operate machinery if they do not feel well.

Important information on some ingredients of Zinnat
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• Zinnat contains parabens (methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216)), which may cause allergic reactions (including delayed-type reactions).
• Zinnat contains 0.00506 mg of sodium benzoate in each tablet.
• The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
  • Consult your doctor to determine whether Zinnat is suitable for the patient.

3. How to use Zinnat

This medicine should always be used exactly as directed by your doctor or pharmacist. If you
have any doubts, contact your doctor or pharmacist again.
Zinnat is available in the following strengths: 125 mg, 250 mg, 500 mg.
Zinnat should be taken after food. This will help increase the effectiveness of treatment.
Zinnat tablets should be swallowed whole with water.
Do not chew, crush or split the tablets – this may reduce the effectiveness of treatment.

Recommended dose
Adults and children with body weight of 40 kg or more
The recommended dose of Zinnat is 250 mg to 500 mg twice daily, depending on the
severity and type of infection.

Children weighing less than 40 kg
Children with body weight below 40 kg should preferably be treated with Zinnat oral suspension.
The recommended dose of Zinnat is 10 mg/kg body weight (not exceeding 250 mg) to 15 mg/kg body weight (not exceeding 250 mg) twice daily, depending on the severity and type of infection.

Zinnat is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group have not been established.

Depending on the disease and the patient's response to treatment, the initial dose may be adjusted or more than one treatment course may be required.

Patients with kidney problems
If this applies to the patient, the doctor may adjust the dosage of the medicine.

• The patient should inform the doctor if this applies.

Taking more Zinnat than recommended
If a patient takes more Zinnat than recommended, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).

• Contact a doctor immediately or call emergency services. If possible, show the Zinnat packaging.

Missing a dose of Zinnat
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment with Zinnat
Do not stop taking Zinnat unless instructed by your doctor.
It is important not to shorten the prescribed treatment duration. Do not stop treatment without your doctor's advice, even if you feel better. Shortening the recommended treatment period may lead to recurrence of the infection.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Conditions to be aware of
In a small number of people taking Zinnat, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
  • Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
  • Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).
• Skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the center surrounded by a lighter ring and a dark outer ring).
• Widespread skin lesions with blisters and peeling of the outer skin layer. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's syndrome).

Other conditions to be aware of during treatment with Zinnat

• Fungal infections. Medicines such as Zinnat may cause overgrowth of yeast ( Candida ) in the body, which may lead to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Zinnat is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zinnat may cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction. During treatment with Zinnat for Lyme disease, some patients may experience high temperature (fever), chills, muscle and headache, and skin rash. This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.
• If any of these symptoms occur in a patient, immediate contact should be made with a doctor or nurse.

Common adverse reactions
May occur in no more than 1 in 10 patients :

• fungal infections (e.g. candidiasis)
• headache
• dizziness

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• diarrhoea
• nausea
• stomach pain.

Common adverse reactions that may be revealed in blood tests:

• increased number of white blood cells (eosinophilia)
• increased liver enzyme activity.

Uncommon adverse reactions
May occur in no more than 1 in 100 patients :

• vomiting
• skin rashes.

Uncommon adverse reactions that may be revealed in blood tests:

• decreased number of platelets (cells involved in blood clotting)
• decreased number of white blood cells (leukopenia)
• positive Coombs' test result.

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• hepatitis.

Adverse reactions that may be revealed in blood tests:

• excessive breakdown of red blood cells (haemolytic anaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Zinnat

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use if the tablets are broken or otherwise damaged.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Contents of the pack and other information

What Zinnat contains

• The active substance is cefuroxime: each film-coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulphate, hydrogenated vegetable oil, colloidal anhydrous silica, coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), Opaspray White M-1-7120J (containing, among others, titanium dioxide (E171) and sodium benzoate (E211)).

What Zinnat looks like and contents of the pack
The film-coated tablets are white, capsule-shaped, smooth on one side and engraved with "GX
EG2" on the other. The tablets are packed in aluminium/aluminium blisters in a cardboard box.
Pack sizes: 10, 20, or 50 film-coated tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Sandoz d.d., Verovškova ulica 57, 1000 Ljubljana, Slovenia
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
Lek Farmacevtska družba d.d. (Lek Pharmaceuticals d.d.)
Verovškova ulica 57, Ljubljana, 1526, Slovenia
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Bulgaria, the country of export: 20020075
Parallel Import Authorisation Number: 181/20
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain,
United Kingdom (Northern Ireland) – Zinnat
Germany – Elobact
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugal – Zoref
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